NorthWest Biotherapeutics Inc (NWBO)

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https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2734629

Of the 249 applications (188 NDAs and 61 BLAs), 222 (89.2%) were disclosed in at least 1 public medium (Figure), including in a press release for 196 applications (78.7%) (Table). Of the press releases, 196 (86.2%) were found on applicants’ websites. Of the applications, 157 (63.1%) were disclosed in SEC filings, including 136 (54.6%) in press releases and SEC filings. The overall rates of public disclosures increased from 87.5% in 2010 to 97.6% in 2016. Publicly traded companies were more likely to disclose applications in any medium compared with nonpublic companies (relative risk, 1.43; 95% CI, 1.09-1.90); private companies were less likely to disclose applications (relative risk, 0.70; 95% CI, 0.53-0.92) (Table). The median time to disclosure was 6 days (IQR, 1-63 days) for press releases, 55 days (IQR, 9-86 days) for SEC filings, and 6 days (IQR, 1-63 days) for any public media.

Current regulations prohibit the US Food and Drug Administration (FDA) from publicly disclosing the existence of pending New Drug Applications (NDAs) or Biologics License Applications (BLAs) unless previously publicly disclosed or acknowledged.1 Applicants may disclose applications in press releases, Securities and Exchange Commission (SEC) filings, or in other media; how frequently they do so is not known.